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BillionToOne IPO to Drive cfDNA-Based Diagnostics Across Prenatal and Oncology Care

BillionToOne IPO, cell free dna testing, cfdna testing, cfDNA

The company’s UNITY test helps identify recessive conditions and common chromosomal findings earlier in pregnancy.

BillionToOne completed its upsized IPO, raising approximately $273.1 million through the sale of 4,551,100 shares at $60 each. The company’s Class A common stock began trading on the Nasdaq Global Select Market on November 6 under the ticker BLLN, with the offering closing on November 7.

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Based in Menlo Park, BillionToOne is a molecular diagnostics company focused on making high-accuracy DNA tests more accessible. Its platform centers on sensitive measurement of cell-free DNA (cfDNA), small fragments released into the bloodstream as cells naturally die. During pregnancy, some cfDNA comes from the placenta and reflects fetal genetics; in cancer, a small portion originates from tumor cells or damaged tissues.

Understanding what makes cfDNA unique helps explain its growing role in both prenatal care and oncology.

Because cfDNA changes rapidly as disease evolves or treatment begins, blood-based testing can support monitoring in real time. Beyond single mutations, cfDNA carries additional layers of information. Features such as fragment size, fragment ends, methylation patterns and nucleosome footprints can help identify tissue of origin and underlying biology, even when classic mutation signals are limited. Since disease-related fragments are rare and can be affected by background noise, methods that can accurately measure very low-frequency fragments and correct for technical bias hold particular value.

In prenatal care, this biology underpins noninvasive prenatal testing, where fetal cfDNA in maternal blood is analyzed to estimate the risk of conditions such as trisomy 21, 18 and 13.

Chromosomal abnormalities are a leading cause of prenatal pregnancy loss, with aneuploidies and structural abnormalities commonly identified in miscarriages.

In oncology, cfDNA can reveal actionable mutations, track treatment response and support minimal residual disease (MRD) assessment.

Detecting these signals requires high analytical sensitivity. BillionToOne’s platform is designed to improve precision at extremely low signal levels and extract clinically relevant patterns from a standard blood draw.

The company’s technology architecture includes synthetic DNA fragments known as Quantitative Counting Templates, which act as built-in controls during processing. These fragments undergo the same steps as patient samples, allowing the system to correct for laboratory variability and support consistent measurements. Machine learning and advanced analytics further refine signal interpretation.

This same foundation supports the company’s UNITY prenatal screen, Northstar oncology assays and upcoming MRD program.

UNITY, launched in 2019, screens for fetal risk of recessive inherited conditions, including sickle cell disease and cystic fibrosis, without requiring a paternal sample. The same blood draw can also assess common chromosomal conditions, reflecting the broader move toward accessible, noninvasive prenatal screening.

In May, BillionToOne expanded its UNITY Fetal Risk Screen to assess up to 14 clinically actionable recessive and X-linked conditions, building on its original 5-gene panel. The updated screen provides pregnancy-specific fetal risk estimates as early as nine weeks using a single maternal blood sample and does not require a partner sample.

The platform applies Quantitative Counting Template (QCT) technology to analyze maternal carrier status and fetal cfDNA at single-base-pair resolution. This enables a more precise fetal risk estimate than traditional carrier screens that rely on general population probabilities.

In oncology, Northstar Select provides genomic profiling to support therapy selection for advanced solid tumors, while Northstar Response tracks chemical markers associated with cancer activity to monitor changes over time. The assays give clinicians both a genomic view of the cancer and a dynamic measure of treatment response.

BillionToOne reported processing more than 508,000 tests in the year ending June 30, 2025, surpassing 1 million tests since launch. In oncology, more than 95% of clinicians who order testing use both Northstar assays.

The company’s MRD test is designed to detect trace levels of cancer DNA following treatment and is slated for launch in 2026 as a laboratory-developed test. Early cancer detection remains a longer-term research direction.

Overall, cfDNA testing offers a minimally invasive, repeatable way to capture time-sensitive biological signals from a single blood draw. BillionToOne operates within a broader ecosystem of companies developing cfDNA-based diagnostics and enabling technologies. Its IPO proceeds are earmarked for expanding its diagnostics platform, laboratory infrastructure and R&D efforts, including new assays, advanced analytics and additional clinical applications.


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